Assessment of Skin Lesions Using a Tissue Oxygen Imager Based on Protoporphyrin IX (PPIX) Fluorescence. This is an Open-label, Non-randomized, Feasibility Study That Includes a One-time Application of an FDA Approved Medication Followed by Local Imaging for Benign Skin Growth and Lesions Clinically

Dartmouth Health

Status: Enrolling

Conditions: Benign Skin Growth; Non-Melanoma Skin Cancer (NMSC)

Treatments: Drug: Ameluz 10% Topical Gel; Device: Protoporphyrin IX

Study type: Observational

Funder types: Other

Identifiers

NCT07201376

STUDY02002181

Details and patient eligibility

About

The primary objective of this study is the evaluation of the efficacy of the tissue oxygen imager based on PpIX DF in differentiating benign skin growth from non-melanoma skin cancer (NMSC).

Full description

The present study is an open-label, non-randomized, feasibility study aiming to evaluate the ability of a non-significant risk tissue oxygen imager based on protoporphyrin IX (PpIX) delayed fluorescence (DF) for differentiating benign from malignant skin lesions and assessing tumor margins during Mohs micrographic surgery.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults ≥ 18 years of age.
• Histologic proof of non-melanoma skin cancer. Patients with different skin tones based on the Fitzpatrick Scale, who present with skin growth or lesions and are scheduled for resection.
• As determined by the enrolling physician or study team member, the patient must have the willingness and ability to understand and comply with study procedures.
• Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of study.
• Lesions must measure between 5 mm and 3 cm in diameter.

Exclusion criteria

• Patients who are <18 years of age
• Adults who are unable to provide informed consent.
• Known allergy to Ameluz
• Photosensitivity or photodermatoses or similar conditions.
• Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol, in the opinion of the investigator
• Known hypersensitivity to porphyrins or to any component of Ameluz, including soya bean phosphatidylcholine.
• Females who are currently breast-feeding